Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section

Ketamine

Brief Summary

This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.

Intervention / Treatment

  • Ketamine (DRUG)
    the analgesic affects of ketamine will be compared between the experimental and placebo group.
  • Placebo (DRUG)
    the analgesic requirement will be calculated in placebo group.

Condition or Disease

  • Non Elective Cesarean Section and Ketamine Analgesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 35 Years
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2018 ACTUAL
    Primary Completion: Mar 07, 2019 ACTUAL
    Completion Date: Mar 07, 2019 ACTUAL
    Study First Posted: Mar 01, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 19, 2019

    Sponsors / Collaborators

    Lead Sponsor: B.P. Koirala Institute of Health Sciences
    Responsible Party: N/A

    Location

    Koshi, Nepal
    Dharān Bāzār, Koshi, Nepal

    Participant Groups

    • the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.

    • they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 35
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * • All women at term(\>or =37 weeks of gestation)

    * Healthy
    * American Society of Anesthesiologists(ASA) class1 and 2
    * Women undergoing non-elective caesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and fentanyl

    Exclusion Criteria:

    * • Women with American society of anesthesiologist physical status\>2

    * Body mass index \>or =40 kg per square meter
    * Height \<150 cm
    * Any contraindication to the spinal anesthesia
    * History of substance abuse
    * History of hallucinations
    * Chronic opioid therapy
    * Chronic pain or on any pain medication currently
    * Patient with maternal complications,like cardiovascular disease pre-eclampsia,diabetes,multiple gestation,known fetal abnormality
    * Cases with severely compromised fetus where immediate administration of general anesthesia is required.

    Primary Outcomes

    • Total opioid required up to 24 postoperatively in ketamine and placebo group.

    Secondary Outcomes

    • • Postoperative NRS Scores (on arrival to Post operative care unit), 2, 4, 6, 8, 12 and 24 h ).The NRS ranges from 0- 10 and 0 refers to no pain and 10 means extreme possible pain perceived.

    • Time to first perception of pain

    • Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h

    More Details

    NCT Number: NCT03450499
    Other IDs: IRC/1089/017
    Study URL: https://clinicaltrials.gov/study/NCT03450499
    Last updated: Sep 29, 2023